Sterilization and Controlled Temperature Environment Validation

Sterilization and Controlled Temperature Environment Validation

This course provides participants with an in-depth understanding of steam sterilization as well as the current methods of validation for sterile processes in the pharma/biotech manufacturing environment, including Autoclaves and Steam in Place (SIP) Systems, by providing a thorough understanding of sterilization, sterile equipment design, the regulatory requirements associated with sterilization and the methods used to test and validate sterile processes.

In addition, this course provides participants with an in depth understanding of controlled temperature environments, as well as, the current methods used to validate them in the biotech/pharmaceutical industry.  Equipment covered includes validation of incubators, cold rooms, warehouses and freezers.

This course must be taught at a BioNetwork location.

Level: Intermediate
Lecture Hours: 12.00
Lab Hours: 12.00
Total Contact Hours: 24.00

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Topics Include

This three day, 24 hour course covers the following topics:

  • Introduction to Steam Sterilization
  • Autoclave and SIP Design
  • Regulatory Requirements
  • Acceptance Criteria
  • Autoclave and SIP Testing/Validation
  • Field  Autoclave and SIP Cycle Analysis
  • Controlled Temperature Environments
  • Field Validation Techniques

Learning Objectives

The objectives of this course are to provide a thorough understanding of:

  • Steam sterilization
  • Sterile equipment design
  • Regulatory requirements associated with steam sterilization
  • The methods used to test and validate sterile processes
  • Controlled temperature environments including design, regulatory requirements, testing, and validation

Audience

This course is designed for entry level process technicians, autoclave specialists, process engineers and those with responsibilities pertaining to component preparation, autoclave and SIP operations.